Senior Medical Director, Medical Affairs

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the medical management of assigned clinical trials in the role of Medical Monitor.

• Act as the Global Lead Medical Monitor for regional and/or global clinical trials.

• Collaborate with Medical & Safety project team members to handle Serious Adverse Events.

• Provide therapeutic and protocol-specific training to project teams.

• Contribute medical insights to clinical development programs, study protocols, research papers, and client-focused white papers.

• Offer after-hours medical support for assigned projects.

• Assist Business Development by generating proposals, conducting feasibility assessments, reviewing proposals/contracts, and participating in sponsor meetings.

• Review or assist in the preparation of final study reports and other relevant study documentation.

• Keep up-to-date with assigned projects, therapeutic advancements, and market developments.

• Engage with other functional areas to ensure successful project execution and client satisfaction.

• Identify, document, and resolve any out-of-scope work.

• Aid in achieving departmental revenue targets and other activities directed by senior management.

• Ensure compliance with ethical, legal, and regulatory standards.

• Mentor fellow medical staff and support leadership within the department and company.

• Maintain clinical and therapeutic expertise through scholarly programs and lectures.

• Conduct SAE-related medical reviews in the electronic safety database.

• Perform additional duties as assigned.

⛳️ Requirements

• Medical Degree from a recognized institution of Medical Education.

• 6-8 years of experience in the CRO, Pharma, or Biotech industry in a medical monitoring or study physician capacity.

• Possess a valid passport and willingness to travel if necessary.

• Proficient computer skills (Word, Excel, Access).

• Exceptional spoken and written English language skills.

• Strong organizational and time management capabilities.

• Excellent communication abilities.

• Outstanding presentation skills.

• Knowledgeable in GCPs and regulatory requirements related to clinical development and safety.

• Proficient in SAE-related medical review within WORLDWIDE's electronic safety database.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.

• Opportunity to work within an inclusive and equitable workplace.